NCT02147431

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the effect of semaglutide on hypoglycaemic counter-regulation compared to placebo in subjects with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started May 2014

Typical duration for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

May 21, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2015

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

May 21, 2014

Last Update Submit

August 9, 2018

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in mean glucagon concentration during hypoglycaemia (change from target level 5.5 mmol/L to nadir (target 2.5 mmol/L))

    After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

Secondary Outcomes (4)

  • Change in mean glucagon concentration from target level 5.5 mmol/L to 3.5 mmoL/L and from ambient plasma glucose to target levels 5.5 mmol/L, 3.5 mmol/L and nadir

    After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

  • Change in mean concentrations of adrenaline, noradrenaline, cortisol and growth hormone from target level 5.5 mmol/L to 3.5 mmol/L and to nadir

    After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

  • Hypoglycaemic symptoms score

    After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

  • Time from termination of insulin infusion at nadir to reach plasma glucose level 4.0 mmol/L

    After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

Study Arms (2)

Semaglutide

EXPERIMENTAL
Drug: semaglutide

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

semaglutideDRUG

2 periods of 12 weeks of once weekly dosing with multiple doses of semaglutide, for subcutaneous (s.c., under the skin) injection, escalated up to 1.0 mg semaglutide. Each treatment period will be followed by a hypoglycaemic clamp

Semaglutide
placeboDRUG

2 periods of 12 weeks of once weekly dosing, subcutaneous (s.c., under the skin) injection. Each treatment period will be followed by a hypoglycaemic clamp.

Placebo

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects diagnosed with type 2 diabetes and on stable treatment for a period of 90 days prior to screening with metformin as monotherapy. Stable is defined as unchanged dose
  • Male or female, age between18-64 years (both inclusive) at the time of signing informed consent
  • Body Mass Index (BMI) between 20.0-35.0 kg/m\^2 (both inclusive)
  • HbA1c (glycosylated haemoglobin) between 6.5-10.0% (both inclusive)

You may not qualify if:

  • Treatment with any glucose lowering agent(s) other than metformin in a period of 90 days before screening. An exception is short-term treatment (less than or equal to 7 days in total) with insulin in connection with intercurrent illness
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
  • Blood or plasma donation within the past month or more than 500 mL within the last 3 months prior to first semaglutide dosing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Graz, 8010, Austria

Location

Related Publications (1)

  • Korsatko S, Jensen L, Brunner M, Sach-Friedl S, Tarp MD, Holst AG, Heller SR, Pieber TR. Effect of once-weekly semaglutide on the counterregulatory response to hypoglycaemia in people with type 2 diabetes: A randomized, placebo-controlled, double-blind, crossover trial. Diabetes Obes Metab. 2018 Nov;20(11):2565-2573. doi: 10.1111/dom.13422. Epub 2018 Jul 16.

    PMID: 29893488RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2014

First Posted

May 26, 2014

Study Start

May 21, 2014

Primary Completion

May 20, 2015

Study Completion

May 20, 2015

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

AU(1)